MASTERGRAFT® STRIP

GUDID 00613994407801

STRIP 7800320 MASTERGRAFT STRIP 20CM

MEDTRONIC SOFAMOR DANEK, INC.

Bone matrix implant, animal-derived, bioabsorbable
Primary Device ID00613994407801
NIH Device Record Key4559833f-586a-4402-84e5-d8d764f18161
Commercial Distribution StatusIn Commercial Distribution
Brand NameMASTERGRAFT® STRIP
Version Model Number7800320
Company DUNS830350380
Company NameMEDTRONIC SOFAMOR DANEK, INC.
Device Count1
DM Exemptfalse
Pre-market Exemptfalse
MRI Safety StatusLabeling does not contain MRI Safety Information
Human Cell/Tissue Productfalse
Device Kitfalse
Device Combination Productfalse
Single Usetrue
Lot Batchtrue
Serial Numberfalse
Manufacturing Datefalse
Expiration Datefalse
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latexfalse
RX Perscriptiontrue
OTC Over-The-Counterfalse

Customer Support Contacts

Phone+1(800)633-8766
EmailCorporate.UDI@medtronic.com
Phone+1(800)633-8766
EmailCorporate.UDI@medtronic.com

Device Dimensions

Width2 Centimeter
Width2 Centimeter
Width2 Centimeter
Width2 Centimeter
Width2 Centimeter
Width2 Centimeter
Width2 Centimeter
Width2 Centimeter

Device Identifiers

Device Issuing AgencyDevice ID
GS100613994407801 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

MQVFILLER, BONE VOID, CALCIUM COMPOUND

Sterilization

Steralize Prior To Usefalse
Device Is Steriletrue

Device Entry Metadata

Public Version StatusUpdate
Device Record StatusPublished
Public Version Number3
Public Version Date2018-07-06
Device Publish Date2015-07-20

On-Brand Devices [MASTERGRAFT® STRIP]

00613994487339STRIP 7800336 MASTERGRAFT 36 CM
00613994407818STRIP 7800310 MASTERGRAFT STRIP 10CM
00613994407801STRIP 7800320 MASTERGRAFT STRIP 20CM
00643169719385STRIP 7800336 MASTERGRAFT STRIP 36CM
00643169719378STRIP 7800320 MASTERGRAFT STRIP 20CM
00643169719361STRIP 7800310 MASTERGRAFT STRIP 10CM
00643169486485STRIP 7800336 MASTERGRAFT 36 CM
00643169486478STRIP 7800320 MASTERGRAFT STRIP 20CM
00643169486461STRIP 7800310 MASTERGRAFT STRIP 10CM

Trademark Results [MASTERGRAFT]

Mark Image

Registration | Serial
Company
Trademark
Application Date
MASTERGRAFT
MASTERGRAFT
78112930 2921419 Live/Registered
MEDTRONIC SOFAMOR DANEK USA, INC.
2002-03-06

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